NCT04809064 · University of Pittsburgh
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
(OASIS)
What this study is about
This clinical trial will determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among patients with acute or recurrent anterior shoulder instability with subcritical bone loss.
View original scientific description
This clinical trial will determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among patients with acute or recurrent anterior shoulder instability with subcritical bone loss. The results of the study assist in optimizing time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss. This study will provide a critical clinical advancement of a previously unaddressed and common clinical scenario.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Civilians and military personnel ages 17 to 50
- Traumatic anterior shoulder dislocation
- Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan, MRI, or 3D-MRI scan
- Had shoulder instability surgery using either 1) arthroscopic Bankart repair with remplissage of Hill-Sachs lesion; 2) open Bankart; or 3) Latarjet
Exclusion criteria
- Chronic, non-traumatic multi-directional instability based on clinical exam
- Concurrent shoulder injury in the involved shoulder (e.g., rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade \>2)
- Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet \[previous isolated arthroscopic Bankart repair only would not be an exclusion criterion\], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery)
- Prior rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery
- Humeral sided bone lesions (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed
- Neuromuscular, neurological and other movement control pathologies including seizures
- Vascular injury associated with the shoulder trauma that compromise adequate/normal healing or interferes with usual course of care
- Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines
- Cartilage lesion finding in the involved shoulder that would interfere with usual course of care
- Known pregnancy at time of imagining and/or surgery based upon standard of care testing procedures
- Any issue with the contralateral shoulder that would preclude participation in research procedures
- Any condition in the opinion of the investigator/clinician that would preclude or limit full participation in study activities
- Absence of a fixed address or no means of contact
- Known inability to be available at all follow-up time points
- Does not plan to return to pre-injury levels of work, sports or military duty
Where
- Tempe, Arizona
- San Diego, California
- Vail, Colorado
- Farmington, Connecticut
- Annapolis, Maryland
- Bethesda, Maryland
- Chapel Hill, North Carolina
- Durham, North Carolina
- Marine Corps Base Camp Lejeune, North Carolina
- Winston-Salem, North Carolina
- Columbus, Ohio
- Pittsburgh, Pennsylvania
And 3 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations